๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2407467 52 F OR 08/10/2022 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 939909
939909
939909
939909
032H21A
032H21A
032H21A
032H21A
Allergy test, Biopsy, Blood test, Computerised tomogram, Disturbance in attentio... Allergy test, Biopsy, Blood test, Computerised tomogram, Disturbance in attention; Endoscopy, Headache, Magnetic resonance imaging, Migraine, Pyrexia; Swelling face, Vision blurred, X-ray dental; Magnetic resonance imaging head, New daily persistent headache; Allergy test, Biopsy, Blood test, Computerised tomogram, Disturbance in attention; Endoscopy, Headache, Magnetic resonance imaging, Migraine, Pyrexia; Swelling face, Vision blurred, X-ray dental; Magnetic resonance imaging head, New daily persistent headache; Biopsy, Computerised tomogram, Head discomfort, Headache, Hypoaesthesia oral; Magnetic resonance imaging head, Oral pain, Pain, Periorbital pain, Rhinalgia More
The day after I received the shot, I had an extremely high fever and a migraine. The migraine hasn&#... The day after I received the shot, I had an extremely high fever and a migraine. The migraine hasn't gone away. I have chronic swelling on both cheek bones. The swelling in conjunction with the headaches has made it difficult for me to focus and sometimes results in blurred vision. After I received the second shot in the series, I also had adverse effects, but those dissipated. I see my primary doctor regularly. He's referred me to an ENT and a neurologist- I have seen both and have had multiple appointments with the neurologist. Unfortunately, I am still suffering each day. More
2841887 05/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
Shingles; This non-serious case was reported by a consumer via interactive digital media and describ... Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 14-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the 1st vaccination and got shingles, it was a horrible nightmare. More
2841888 05/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Influenza like illness Influenza like illness
flu like side effects; This non-serious case was reported by a consumer via interactive digital medi... flu like side effects; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included facial droop (was in the hospital for a week in January) and watering eyes. Additional patient notes included sagging left side of mouth. On 14-MAY-2025, the patient received the 1st dose of Shingles vaccine. In MAY-2025, less than a week after receiving Shingles vaccine, the patient experienced influenza like illness (Verbatim: flu like side effects). The outcome of the influenza like illness was not resolved. It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine. It was unknown if the company considered the influenza like illness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAY-2025 This case was reported by a patient via interactive digital media. Patient got the first vaccine shot and was having some flu-like side effects. More
2841889 05/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Feeling abnormal, Herpes zoster, Vaccination failure Feeling abnormal, Herpes zoster, Vaccination failure
am suffering with my second outbreak /both arms and left hip/ Some on my neck and under my chin; 1st... am suffering with my second outbreak /both arms and left hip/ Some on my neck and under my chin; 1st was last September/ Then was right arm; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In SEP-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 1st was last September/ Then was right arm). On an unknown date, the patient experienced shingles (Verbatim: am suffering with my second outbreak /both arms and left hip/ Some on my neck and under my chin). The outcome of the vaccination failure and shingles were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated he/she also been vaccinated and was suffering with second outbreak. The patient had 1st in last September and then was right arm. The patient stated this time both arms and left hip and some on neck and under chin. The patient stated it was miserable and he/she will be 80 in a couple of weeks. The patient stated it was not the way wanted to celebrate his/her birthday This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2841890 05/20/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Pain in extremity; Pain in extremity Pain in extremity; Pain in extremity
Sore arm; This non-serious case was reported by a consumer via interactive digital media and describ... Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 53-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Family history included shingles (Sister got shingles at 49). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The patient made his/her appointment and got both shots of Shingles vaccine and had just a sore arm. The patient reported he/she glad to had vaccine, if he/she get it would be mild. More
2841891 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
got my first shingrix vaccine in 2023.; This non-serious case was reported by a consumer via interac... got my first shingrix vaccine in 2023.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got my first shingrix vaccine in 2023.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 13-MAY-2025 The patient got his/her first dose of Shingrix vaccine in 2023. The patient had a questioned should he/she still get the second dose even though it had been two years later. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2841892 1 M IL 05/20/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 AK334
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
a vaccine given to a 2 years old, it was the Boostrix instead of the infanrix; a vaccine given to a ... a vaccine given to a 2 years old, it was the Boostrix instead of the infanrix; a vaccine given to a 2 years old, it was the Boostrix instead of the infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number AK334, expiry date 14-JUN-2027) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. On 30-APR-2025, the patient received the 1st dose of Boostrix. On an unknown date, the patient received Infanrix. On 30-APR-2025, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: a vaccine given to a 2 years old, it was the Boostrix instead of the infanrix) and inappropriate age at vaccine administration (Verbatim: a vaccine given to a 2 years old, it was the Boostrix instead of the infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-MAY-2025 Registered Nurse reported that yesterday, there was a vaccine given to a 2 years old, it was the Boostrix instead of the Infanrix, which led to Wrong vaccine administered and Inappropriate age at vaccine administration. And reporter was just wanting to see if there are any adverse reactions or anything that need to do on our end besides the incident report. The reporter Consented to follow up. HCP stated that the 2 years old patient was supposed to receive the 4th dose of Infanrix. More
2841893 M IN 05/20/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
they did not get their 2nd one; This non-serious case was reported by a pharmacist via call center r... they did not get their 2nd one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrox (received first dose on 20-FEB-2025). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: they did not get their 2nd one). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-MAY-2025 Reporter stated that one of their patients got Twinrix on 20-FEB-2025, but they did not get their 2nd one, they were just wondering if they have to restart the series over or just to the 2nd one now. Till the time of reporting the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination. More
2841894 64 F FL 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered, Injection site reaction Extra dose administered, Injection site reaction
topical reaction at the site of the injection; A 64 years old female patient received an extra dose ... topical reaction at the site of the injection; A 64 years old female patient received an extra dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on 30th April 2019) and Shingrix (received 2nd dose of vaccine on 20th July 2019). On 13-FEB-2025, the patient received the 3rd dose of Shingrix. On 13-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: A 64 years old female patient received an extra dose of Shingrix). On an unknown date, the patient experienced injection site reaction (Verbatim: topical reaction at the site of the injection). The outcome of the injection site reaction was resolved and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the injection site reaction to be related to Shingrix. It was unknown if the company considered the injection site reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 06-MAY-2025 On 6th May 2025, a pharmacist called to report that a 64 year old female patient had received an extra dose of Shingrix by mistake. The first dose had been administered on 30th April 2019, followed by the second dose on 20th July 2019. On 13th February 2025, a third dose had mistakenly been given, which led to Extra dose administered. The patient had experienced a reaction and had visited her medical provider, who had pulled some titers tests and reviewed her medical records. A medical professional had identified a topical reaction at the injection site. The patient was not immunocompromised. The pharmacist stated that the patient was fine. More
2841895 TN 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
has not gotten a second dose of Shingrix; This non-serious case was reported by a physician via sale... has not gotten a second dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not gotten a second dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 06-MAY-2025 The physician reported that if a patient went beyond 6 months and has not gotten a second dose of Shingrix does the patient start the 2 dose series over again or just get the second shot even if it is past 6 months. No further details available. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2841896 F MO 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Hypoaesthesia Hypoaesthesia
left leg was numb from the knee down to the toes; This non-serious case was reported by a pharmacist... left leg was numb from the knee down to the toes; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of numbness of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (Nothing happened after Shingrix first dose). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced numbness of extremities (Verbatim: left leg was numb from the knee down to the toes). The outcome of the numbness of extremities was resolved (duration 6 months). It was unknown if the reporter considered the numbness of extremities to be related to Shingrix. It was unknown if the company considered the numbness of extremities to be related to Shingrix. Additional Information: GSK receipt date: 06-MAY-2025 Physician reported that after Shingrix second dose, her left leg was numb from the knee down to the toes for 6 months. Also indicated that nothing happened after Shingrix first dose. More
2841897 M FL 05/20/2025 HEP
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Potential inappropriate schedule.; This non-serious case was reported by a pharmacist via call cente... Potential inappropriate schedule.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 41-year-old male patient who received Hepatitis B vaccine for prophylaxis. Previously administered products included Hepatitis B (patient received a dose of Hep B vaccine back in 1998). On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: Potential inappropriate schedule.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 07-MAY-2025 Other HCP reported that a patient received a dose of Hepatitis B vaccine back in 1998 and never got another one to complete the series, which led to incomplete course of vaccination. Reporter did not know which was the brand name of such Hepatitis B vaccine, so they didn't know if it was Engerix B or not. No more details were given by reporter. Did not consent to follow-up. More
2841898 F CA 05/20/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
UNK
Product administered to patient of inappropriate age, Product prescribing error;... Product administered to patient of inappropriate age, Product prescribing error; Product administered to patient of inappropriate age, Product prescribing error More
Bexsero possible out of the recommended age administration; received another dose on 24 AUG 2024; sh... Bexsero possible out of the recommended age administration; received another dose on 24 AUG 2024; she was administered BEXSERO on 23 JUN 2023; This non-serious case was reported by a consumer via sales rep and described the occurrence of product prescribing error in a 71-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis. The patient's past medical history included splenectomy (her spleen was removed in June 2023). On 23-JUN-2023, the patient received the 1st dose of Bexsero. On 24-AUG-2024, the patient received the 2nd dose of Bexsero. On 23-JUN-2023, an unknown time after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: she was administered BEXSERO on 23 JUN 2023). On 24-AUG-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: received another dose on 24 AUG 2024). On an unknown date, the patient experienced product prescribing error (Verbatim: Bexsero possible out of the recommended age administration). The outcome of the product prescribing error, inappropriate age at vaccine administration and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 07-MAY-2025 Physician prescribed Bexsero every two years, but when she went to the pharmacy, she was denied the vaccine (given that she was over 25 years old, above the upper age limit recommended in the vaccine's prescribing information). The patient went to the hospital for an injury and received two vaccines (at different times) before going to the pharmacy to try to get Bexsero. Unfortunately, the Medical Information agent's call was disconnected and he was unable to confirm if either of those two vaccines was Bexsero. Also stated that she was in an accident and her spleen was removed in June 2023. Consumer stated she was administered Bexsero on 23 June 2023 and received another dose on 24 August 2024, which led to inappropriate age at vaccine administration. More
2841899 M CO 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 92NN2
Product preparation issue Product preparation issue
a patient was administered only the adjuvant portion or Shingrix; a patient was administered only th... a patient was administered only the adjuvant portion or Shingrix; a patient was administered only the adjuvant portion or Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number 92NN2, expiry date 30-MAR-2027) for prophylaxis. On 30-APR-2025, the patient received the 1st dose of Shingrix. On 30-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: a patient was administered only the adjuvant portion or Shingrix) and inappropriate dose of vaccine administered (Verbatim: a patient was administered only the adjuvant portion or Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 08-MAY-2025 The pharmacist reported that a patient was administered only the adjuvant portion or Shingrix (without reconstitution) which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2841900 TX 05/20/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Previous vaccination schedule was being used after October 2024; This non-serious case was reported ... Previous vaccination schedule was being used after October 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Previous vaccination schedule was being used after October 2024). The outcome of the inappropriate schedule of vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-MAY-2025 The Vaccine Administration Facility was the same as Primary Reporter. A medical assistant called in to request data about the vaccination series and different changes that had been done to the schedule. They mentioned that they were receiving lots with the previous Prescribing information. They mentioned that every pediatric patient from October 24th, 2024 onward until today had received the previous schedule, without specifying number, age, gender or status which led to inappropriate schedule of vaccine administered. The reporter declined any type of follow up. More
2841901 F PA 05/20/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 9532Y
Interchange of vaccine products, Product administered to patient of inappropriat... Interchange of vaccine products, Product administered to patient of inappropriate age More
Unapproved age; Interchange of vaccines; This non-serious case was reported by a nurse via call cent... Unapproved age; Interchange of vaccines; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9532Y, expiry date 23-MAY-2025) for prophylaxis. Previously administered products included adacel (received her four doses at 9th, 18th, 16th months and 26th months). On an unknown date, the patient received the 1st dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age) and interchange of vaccine products (Verbatim: Interchange of vaccines). The outcome of the inappropriate age at vaccine administration and interchange of vaccine products were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-MAY-2025 Reporter stated that a child five years old, was seen at children's for her last erasion, she was in line with her immunizations. However, when she went to the hospital this last erasion, they decided to give her a tdap, she is five, she got the tdap which was Adacel. So, apparently, while they were there, the provider decided that child needed the tdap shot, because they had four shots but not a fifth of her dtap. They wanted to know if they need to perform another dtap, if they have already an adult tdap that was given, given that the child already received her four others at 9th, 18th, 16th months and 26th months and they turned around and gave her this tdap, in this past year. Also wanted to know if she is covered then given the amount in this vaccine, is it appropriate dosing or do they need to give her another dtap or what. She actually had, those previous four doses, were pentacels. The patient received Boostrix at the age of 5 years after four doses of Adacel, which led to interchange of vaccine products and inappropriate age at vaccine administration. More
2841902 51 F 05/20/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient received a late second dose; This non-serious case was reported by a pharmacist via call cen... patient received a late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received first dose of Twinrix vaccine on unknown date 6 months prior). On 12-MAY-2025, the patient received the 2nd dose of Twinrix. On 12-MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received a late second dose). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-MAY-2025 A pharmacist wanted to know if he should give a third dose of Twinrix or restart the series after a patient received a late second dose (6 months after the first dose was given) which led to drug dose administration interval too long. The reporter did not consent to follow-up. More
2841903 MO 05/20/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
Admin. after below temperature excursion; This non-serious case was reported by a other health profe... Admin. after below temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and RSVPreF3 adjuvanted (Arexvy) for prophylaxis. In APR-2025, the patient received Pediarix, Infanrix, Havrix, Engerix B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy. In APR-2025, an unknown time after receiving Pediarix, Infanrix, Havrix, Engerix B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy and an unknown time after receiving Pediarix, Infanrix, Havrix, Engerix B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy, the patient experienced incorrect storage of drug (Verbatim: Admin. after below temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 12-MAY-2025 On 12th May 2025 a Clinic manager/AMAS called to report a temperature excursion for Pediarix, Infanrix, Havrix, Engerix-B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy. Healthcare professional reported that since 07th April 2025 the vaccines were exposed to below recommended temperatures, and on 29th April 2025 the products were exposed to a minimum temperature of 29.9 ๏ฟฝF which led to incorrect storage of drug. Healthcare professional asked that so patients that had been vaccinated during those excursions, during that time frame, do they need to be revaccinated? or what's the protocol for that? During the call, Healthcare professional did not share any patient information, she said that at the moment of the call, she did not have any information due to the situation, they add the list of all the vaccines, but they don't have the details of which patients received which vaccine. More
2841904 M 05/20/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 2JX7Y
Product preparation issue Product preparation issue
Priorix administration of only the diluent portion; Priorix administration of only the diluent porti... Priorix administration of only the diluent portion; Priorix administration of only the diluent portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 45-year-old male patient who received MMR (Priorix) (batch number 2JX7Y, expiry date 01-JUN-2026) for prophylaxis. On 13-MAY-2025, the patient received Priorix. On 13-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Priorix administration of only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: Priorix administration of only the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 13-MAY-2025 A nurse called to report that a patient was given only the diluent portion of the Priorix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administration. The nurse asked for safety information concerning this situation. More
2841905 NY 05/20/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Inappropriate schedule of product administration Inappropriate schedule of product administration
second dose was given one year after the first one; This non-serious case was reported by a nurse vi... second dose was given one year after the first one; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received 1st dose of Bexsero vaccine a year ago). On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: second dose was given one year after the first one). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-MAY-2025 A registered nurse wanted to know how much time could pass between the first and second dose of Bexsero that keeps valid the administration. Information found in the prescribing information was given regarding the two and three-dose schedule administration. Then, the health care provider asked if it would be valid if the second dose was given one year after the first one. The agent asked if one or more patients received the second dose in this condition, to which the health care provider responded it maybe 2 or 3 patients around 18 years old but did not have any data from them nor from the vaccines used. The Vaccine Administration Facility is the same as Primary Reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2841906 M MO 05/20/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 DL32D
Product storage error Product storage error
Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached.; This non-ser... Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) and (batch number 44TR9) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached.). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 The nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Arexvy which led to incorrect storage of drug.; Sender's Comments: US-GSK-US2025061548:SAME REPORTER US-GSK-US2025061546:Same reporter,Different patient More
2841907 M MO 05/20/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 39LB7
Product storage error Product storage error
Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached; This non-seri... Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-MAY-2025 Nurse asked the recommendations after giving Boostrix vaccine that was exposed to a below temperature excursion of 29.9๏ฟฝF as the lowest reached, which led to incorrect storage of drug. This is one of the three linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025061548:SAME REPORTER US-GSK-US2025061546:Same reporter,Different patient More
2841908 M MO 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 M7G39
Product storage error Product storage error
Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached; This non-seri... Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 Nurse asked the recommendations after giving Shingrix vaccine that was exposed to a below temperature excursion, which led to incorrect storage of drug. This is one of the three linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient More
2841909 F IN 05/20/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 G79C4
Underdose Underdose
pediatric dose of the Havrix vaccine was given to an adult; pediatric dose of the Havrix vaccine was... pediatric dose of the Havrix vaccine was given to an adult; pediatric dose of the Havrix vaccine was given to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 42-year-old female patient who received HAV (Havrix pediatric) (batch number G79C4, expiry date 20-SEP-2025) for prophylaxis. On 15-APR-2025, the patient received Havrix pediatric. On 15-APR-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose of the Havrix vaccine was given to an adult) and underdose (Verbatim: pediatric dose of the Havrix vaccine was given to an adult). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 Nurse reported that a pediatric dose of the Havrix vaccine was given to an adult patient, which led to adult use of child product and underdose. More
2841910 F 05/20/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7ZM55
7ZM55
Abdominal discomfort, Chills, Headache, Hypersomnia, Malaise; Pain in extremity,... Abdominal discomfort, Chills, Headache, Hypersomnia, Malaise; Pain in extremity, Pyrexia More
fever; shakings chills; upset stomach; crushing headache; arm soaring; This non-serious case was rep... fever; shakings chills; upset stomach; crushing headache; arm soaring; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 7ZM55, expiry date 15-NOV-2026) for prophylaxis. On 02-MAY-2025, the patient received Shingrix. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever), chills (Verbatim: shakings chills), upset stomach (Verbatim: upset stomach), headache (Verbatim: crushing headache) and pain in arm (Verbatim: arm soaring). The outcome of the fever, chills, upset stomach, headache and pain in arm were not reported. It was unknown if the reporter considered the fever, chills, upset stomach, headache and pain in arm to be related to Shingrix. It was unknown if the company considered the fever, chills, upset stomach, headache and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 15-MAY-2025 The reporter reported on 15th May 2025, a 53 years old female patient called to report that her pharmacy called her stating that the lot of Shingrix she received may or not may be good so she needed to start again the dosing and receive two more shots. Patient mentioned that she got really sick after getting the dose of Shingrix on 2nd May 2025, like really sick. Patient was upset about it and experienced fever, shakings chills, upset stomach, she did not vomited but she wanted to, and crushing headache, arm soaring, she slept for 2 days because she was sick. Patient asked how did you know that the vaccine was works, that if it was good or not. More
2841911 F 05/20/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect product administration duration Incorrect product administration duration
Havrix - Delayed second dose.; This non-serious case was reported by a pharmacist via call center re... Havrix - Delayed second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug administration duration too long in a 60-year-old female patient who received HAV (Havrix) for prophylaxis. Previously administered products included Havrix (received 1st dose in 2009). On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug administration duration too long (Verbatim: Havrix - Delayed second dose.). The outcome of the drug administration duration too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-MAY-2025 The pharmacist mentioned that a patient received the first Havrix vaccine in 2009 and then a second dose of Havrix in 2023. The Healthcare professional asked if the patient should received extra doses. The patient received 2nd dose of Havrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2841912 M CA 05/20/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 72AB2
Incorrect route of product administration Incorrect route of product administration
Priorix was administered via intramuscular; This non-serious case was reported by a nurse via call c... Priorix was administered via intramuscular; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 39-year-old male patient who received MMR (Priorix) (batch number 72AB2) for prophylaxis. On 14-MAY-2025, the patient received Priorix. On 14-MAY-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was administered via intramuscular). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-MAY-2025 Nurse reported that Priorix was administered via intramuscular injection to a patient, which led to subcutaneous injection formulation administered by other route. More
2841913 78 F FL 05/20/2025 COVID19
 MODERNA
Headache, Myalgia Headache, Myalgia
she's got muscle aches, headaches, so every, everything hurts; she's got muscle aches, hea... she's got muscle aches, headaches, so every, everything hurts; she's got muscle aches, headaches, so every, everything hurts; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (she's got muscle aches, headaches, so every, everything hurts) and HEADACHE (she's got muscle aches, headaches, so every, everything hurts) in a 78-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (NOS). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine (NOS). On 07-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MYALGIA (she's got muscle aches, headaches, so every, everything hurts) and HEADACHE (she's got muscle aches, headaches, so every, everything hurts). At the time of the report, MYALGIA (she's got muscle aches, headaches, so every, everything hurts) and HEADACHE (she's got muscle aches, headaches, so every, everything hurts) had not resolved. No concomitant medications were reported. The dose was probably a 4th Moderna COVID shot pretty much every 6 or 7 months or so and she never, never had a problem. The patient took painkillers and fell asleep. The patient was still experiencing the symptoms. She had no fever. More
2841914 60 M AZ 05/20/2025 COVID19
 MODERNA
Arthralgia, Asthenia, Fatigue, Headache, Inflammation Arthralgia, Asthenia, Fatigue, Headache, Inflammation
Inflammation; Weakness; Joint pain; Headache; Fatigue; This spontaneous case was reported by a consu... Inflammation; Weakness; Joint pain; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), ASTHENIA (Weakness), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue) in a 60-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 4 microgram. On 17-Jun-2023, the patient experienced INFLAMMATION (Inflammation), ASTHENIA (Weakness), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, INFLAMMATION (Inflammation), ASTHENIA (Weakness), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported. More
2841915 56 F CA 05/20/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH

Erythema, Injection site swelling, Injection site warmth, Nausea, Pyrexia; Vomit... Erythema, Injection site swelling, Injection site warmth, Nausea, Pyrexia; Vomiting More
Injection site swelling; nausea; vomiting; fever; erythema; hot at the injection site; This is a spo... Injection site swelling; nausea; vomiting; fever; erythema; hot at the injection site; This is a spontaneous report received from a Pharmacist. A 55-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 29Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years for immunisation. The patient's relevant medical history included: "vaccination side effect" (unspecified if ongoing), notes: Has not done well with vaccines in general; similar reaction but not as extreme.; "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 30Apr2025, outcome "unknown", described as "Injection site swelling"; ERYTHEMA (non-serious) with onset 30Apr2025, outcome "unknown"; PYREXIA (non-serious) with onset 30Apr2025, outcome "unknown", described as "fever"; VACCINATION SITE WARMTH (non-serious) with onset 30Apr2025, outcome "unknown", described as "hot at the injection site"; NAUSEA (non-serious) with onset 30Apr2025, outcome "unknown"; VOMITING (non-serious) with onset 30Apr2025, outcome "unknown". It was unknown if therapeutic measures were taken as a result of vaccination site swelling, nausea, vomiting, pyrexia, erythema, vaccination site warmth. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2841916 41 F CA 05/20/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Asthenia, Blood pressure measurement, Haematocrit, Haematocrit abnormal, Haemogl... Asthenia, Blood pressure measurement, Haematocrit, Haematocrit abnormal, Haemoglobin; Haemoglobin abnormal, Heavy menstrual bleeding, Hypertension, Mean cell haemoglobin, Mean cell haemoglobin concentration; Mean cell haemoglobin concentration abnormal, Menstrual disorder, Pallor More
out of range hemoglobin; out of range Hematocrit; out of range MCH/MCHC; heavy bleeding/blood loss; ... out of range hemoglobin; out of range Hematocrit; out of range MCH/MCHC; heavy bleeding/blood loss; menstrual cycle started a few days later but did not stop; paleness; weakness; high blood pressure; This is a spontaneous report received from a Consumer or other non HCP. A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Apr2025 as dose 1, 0.1 ug/ml single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 15Apr2025, outcome "not recovered", described as "heavy bleeding/blood loss"; HYPERTENSION (non-serious) with onset 15Apr2025, outcome "not recovered", described as "high blood pressure"; MENSTRUATION ABNORMAL (medically significant) with onset 15Apr2025, outcome "not recovered", described as "menstrual cycle started a few days later but did not stop"; PALLOR (non-serious) with onset 15Apr2025, outcome "not recovered", described as "paleness"; ASTHENIA (non-serious) with onset 15Apr2025, outcome "not recovered", described as "weakness"; HAEMATOCRIT ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range Hematocrit"; MEAN CELL HAEMOGLOBIN CONCENTRATION ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range MCH/MCHC"; HAEMOGLOBIN ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range hemoglobin". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (29Apr2025) High; Haematocrit: (29Apr2025) out of range; Haemoglobin: (29Apr2025) out of range; Mean cell haemoglobin: (29Apr2025) out of range; Mean cell haemoglobin concentration: (29Apr2025) out of range. Therapeutic measures were taken as a result of heavy menstrual bleeding/menstrual cycle started a few days later but did not stop. Clinical course: The shot was given on 12Apr2025. The menstrual cycle started a few days later but did not stop. On 28Apr and 30Apr patient went to urgent care and doctor. The doctor gave her progesterone birth control to stop the bleeding. Patient has been taking one a day, but period has not ended. As of 18May2025, period has continued and is heavy bleeding. Patient has many expected symptoms from blood loss paleness, weakness, high blood pressure, out of range hemoglobin, hematoctit, MCH and MCHC on 29Apr. A new test will take place soon. Event treatment included Progesterone birth control pills. Patient had no known allergies. The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received. More
2841917 05/20/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
Having arm pain from the shoulder all down to forearms; some serious pain that had been going on for... Having arm pain from the shoulder all down to forearms; some serious pain that had been going on for at least a week; Having arm pain from the shoulder all down to forearms; some serious pain that had been going on for at least a week; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Apr2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2025, outcome "unknown" and all described as "Having arm pain from the shoulder all down to forearms; some serious pain that had been going on for at least a week". Additional information: the patient was probably going to end up having some test run, thinking it will be at the emergency hospital but not sure. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2841918 16 M MI 05/20/2025 COVID19
 PFIZER\BIONTECH
Anxiety, Attention deficit hyperactivity disorder, Depression Anxiety, Attention deficit hyperactivity disorder, Depression
anxiety; depression; attention deficit; This is a spontaneous report received from an Other HCP. A ... anxiety; depression; attention deficit; This is a spontaneous report received from an Other HCP. A 20-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1), administration date: 08Apr2021, for COVID-19 immunization. The following information was reported: ATTENTION DEFICIT HYPERACTIVITY DISORDER (non-serious) with onset 05Apr2024, outcome "unknown", described as "attention deficit"; ANXIETY (non-serious) with onset 02May2024, outcome "unknown"; DEPRESSION (non-serious) with onset 02May2024, outcome "unknown". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500088407 Same Pt/SD, Diff Dose/AE; More
2841919 0.33 M OH 05/20/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 Z92L4
Wrong product administered Wrong product administered
MENVEO INADVERTANTLY DRAWN AND ADMINISTERED INSTEADOF PEDVAXHIB O PATIENT MENVEO INADVERTANTLY DRAWN AND ADMINISTERED INSTEADOF PEDVAXHIB O PATIENT
2841920 32 M WA 05/20/2025 HEP
HEPA
IPV
MMR
TDAP
TYP
YF
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 7NX57
Z003701
Y1A212M
Y015022
U8366AA
X1A271M
UK134AA
Hyperhidrosis, Loss of consciousness, Pallor; Hyperhidrosis, Loss of consciousne... Hyperhidrosis, Loss of consciousness, Pallor; Hyperhidrosis, Loss of consciousness, Pallor; Hyperhidrosis, Loss of consciousness, Pallor; Hyperhidrosis, Loss of consciousness, Pallor; Hyperhidrosis, Loss of consciousness, Pallor; Hyperhidrosis, Loss of consciousness, Pallor; Hyperhidrosis, Loss of consciousness, Pallor More
Client was having conversation when he suddenly put his back and passed out. RN grabbed an ice pack.... Client was having conversation when he suddenly put his back and passed out. RN grabbed an ice pack. 911 called. After 10 seconds client jolted awake. Client appeared pale and diaphoresis. Client on awakening was confused about where he was. Client reorientated and moved to vaccine chair where his feet were elevated and put in supine position. Client's BP taken for 99/57 HR 74 at 1346. Client provided with water. ANS was informed about situation. Client BP retaken at 1405 for 100/65. Client stated he felt better and had no sign of diaphoresis. Client had more color to his face as well. Clients in for appointment with his friend who said he will be driving client home. Client's ICV updated. Client was watched for 30 mins post incident. More
2841921 75 F WA 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 47N3Y
Brain fog, Fatigue, Injection site reaction, Injection site swelling, Sensitive ... Brain fog, Fatigue, Injection site reaction, Injection site swelling, Sensitive skin More
The following day she developed large local swelling at injection site with extreme skin sensitivity... The following day she developed large local swelling at injection site with extreme skin sensitivity. This was followed by severe fatigue and brain fog which have persisted and remain present until today (5/20/2025) More
2841922 82 F GA 05/20/2025 COVID19
 PFIZER\BIONTECH
 md3414
Abdominal distension, Abdominal pain, Diarrhoea, Dyspnoea, Laboratory test norma... Abdominal distension, Abdominal pain, Diarrhoea, Dyspnoea, Laboratory test normal More
Shortness of Breath, Diarrhea, Abdominal pain, Bloating She went to the ER and they ran a bunch... Shortness of Breath, Diarrhea, Abdominal pain, Bloating She went to the ER and they ran a bunch of lab work but did not find anything wrong with her. She is still experiencing symptoms. More
2841923 37 M WA 05/20/2025 COVID19
 MODERNA
 8080803
Muscle swelling Muscle swelling
Patient stated he had muscle swelling Patient stated he had muscle swelling
2841937 0.5 F 05/20/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



Infant irritability, Product preparation issue, Pyrexia, Rash; Product preparati... Infant irritability, Product preparation issue, Pyrexia, Rash; Product preparation issue; Infant irritability, Product preparation issue, Pyrexia, Rash; Product preparation issue More
Nurse prepared pediatric COVID vaccine and missed that the dose needs to be reconstituted with 1.1 m... Nurse prepared pediatric COVID vaccine and missed that the dose needs to be reconstituted with 1.1 mL of normal saline. Nurse did not see instruction for reconstitution on vial or in electronic medical record. Patient administered undiluted vaccine. Father reports patient was symptomatic with fever, fussiness on the night that the vaccine was give. Temp 102.5 F. The following day after vaccine administration patient had a rash and fever (101 F) which both had resolved with tylenol. More
2841938 39 F ND 05/20/2025 MMR
 MERCK & CO. INC.
 Y020516
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
Client was notified within 30 minutes of vaccination to notify provider of receipt of live vaccinati... Client was notified within 30 minutes of vaccination to notify provider of receipt of live vaccination based on immunosuppressive medication that she is taking. Client states that she will call or message her provider through MyChart More
2841939 65 M AL 05/20/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 EB499
Injection site infection, Injection site rash Injection site infection, Injection site rash
The patient developed a rash on May 19th below the right deltoid, partially on the bicep. It was a d... The patient developed a rash on May 19th below the right deltoid, partially on the bicep. It was a diffuse red area marked by inflammation and slightly raised margins. It was approximately 2 inches in diameter. It looked like a localized Arthus reaction. Patient showed me the area on the 20th, and said it had slightly improved with time. He took 1 dose of Tylenol only. He reported the condition had improved within 24 hours. More
2841940 54 M CA 05/20/2025 TYP
 SANOFI PASTEUR
 YZA021M
Hypoaesthesia, Paraesthesia Hypoaesthesia, Paraesthesia
Numbness and tingling sensation like pins and needles from shoulder down to fingertips when at rest Numbness and tingling sensation like pins and needles from shoulder down to fingertips when at rest
2841941 1.25 M PA 05/20/2025 DTAP
DTAP
HIBV
HIBV
PNC20
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
PFIZER\WYETH
 JF7DM
JF7DM
Y2DX4
Y2DX4
MF0425
MF0425
Diarrhoea, Influenza A virus test negative, Influenza B virus test negative, Irr... Diarrhoea, Influenza A virus test negative, Influenza B virus test negative, Irritability, Pyrexia; Weight bearing difficulty; Diarrhoea, Influenza A virus test negative, Influenza B virus test negative, Irritability, Pyrexia; Weight bearing difficulty; Diarrhoea, Influenza A virus test negative, Influenza B virus test negative, Irritability, Pyrexia; Weight bearing difficulty More
Refusal to bear weight and fussiness around 4 hours after immunizations administered. Fever and dia... Refusal to bear weight and fussiness around 4 hours after immunizations administered. Fever and diarrhea the following day, 38.3C in office on 5/20/2025 at 1930. . Treated with NSAID More
2841943 69 F IL 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7349L
Antinuclear antibody positive, Blood test normal, Diplopia, Laboratory test norm... Antinuclear antibody positive, Blood test normal, Diplopia, Laboratory test normal, VIth nerve paralysis More
3 days after receiving the vaccine, I developed diplopia. I was told I had a palsy of my 6th occular... 3 days after receiving the vaccine, I developed diplopia. I was told I had a palsy of my 6th occular nerve on my right side. The double vision is horizontal, and occurs when both eyes are open. If I close either eye, I see single vision. It has been almost 2 months and I still have the double vision. More
2841944 44 F OR 05/20/2025 HPV9
 MERCK & CO. INC.
Condition aggravated, Dry eye, Impaired work ability Condition aggravated, Dry eye, Impaired work ability
SEVERE DRY eye symptoms started the next day after vaccine. Debiliating. Unable to work. I have bee... SEVERE DRY eye symptoms started the next day after vaccine. Debiliating. Unable to work. I have been doing IPL treatments for dry eye and have had no dry eye sumptoms for the past several months until this vaccine. More
2841945 1.17 F NY 05/20/2025 IPV
IPV
IPV
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR


Aphasia, Autoantibody positive, Cytogenetic analysis abnormal, Decreased eye con... Aphasia, Autoantibody positive, Cytogenetic analysis abnormal, Decreased eye contact, Electroencephalogram normal; Encephalopathy, Food refusal, Lethargy, Petit mal epilepsy, Tic; Unresponsive to stimuli, Vomiting More
15 minutes after receiving the vaccine, Patient began vomiting. She refused food for several days, w... 15 minutes after receiving the vaccine, Patient began vomiting. She refused food for several days, was lethargic, and began having facial tics and absence seizures. She stopped speaking and stopped responding to her name. Eye contact was lost. She went from happy and energetic to disengaged and unresponsive. More
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1307847 51 M TX 05/19/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
008C21A
008C21A
008C21A
Cardiomegaly, Dyspnoea, Pneumonia, Polycythaemia vera, Pulmonary oedema; Acute m... Cardiomegaly, Dyspnoea, Pneumonia, Polycythaemia vera, Pulmonary oedema; Acute myocardial infarction, Blood creatine phosphokinase MB, Blood pressure increased, Chest X-ray abnormal, Chest pain; Dizziness, Dyspnoea, Electrocardiogram abnormal, Muscle tightness, Paraesthesia; Pulmonary oedema, Troponin increased More
moderna second 95 water pct water lungs pneumonia , buster give me dysventilation problems to ... moderna second 95 water pct water lungs pneumonia , buster give me dysventilation problems to breath More
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2841511 TX 05/19/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y014510
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Caller reported AE on behalf of a patient who was administered a third dose of GARDASIL 9 before the... Caller reported AE on behalf of a patient who was administered a third dose of GARDASIL 9 before the recommended interval. Patient was administered dose 1 on 10/25/2024, dose 2 on 12/6/2024, and dose 3 on 2/7/2025. No symptoms reported. No additional; no adverse event; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 25-Oct-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection as prophylaxis (dose, lot #, expiration date, anatomical location , and route of administration were not reported). On 06-Dec-2024, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection, as prophylaxis (dose, lot #, expiration date, anatomical location, and route of administration were not reported). On 07-Feb-2025, the was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9), Recombinant Suspension for injection (lot #Y014510, expiration date: was reported as 20-Sep-2025, but upon validation it was found to be 01-Nov-2026) 0.5 mL (0.5ml/dose). Per reporter, the patient received this last dose before the recommended interval (Inappropriate schedule of vaccine administered). No symptoms reported. Lot # is being requested and will be submitted if received. More
2841512 54 M OH 05/19/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 2345b
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
The first dose had been given on February 7, 2025, and the second dose had been given on May 9, 2025... The first dose had been given on February 7, 2025, and the second dose had been given on May 9, 2025, six months earlier; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a 54-year-old male patient who received HAV (Havrix adult) (batch number 2345b, expiry date 02-FEB-2026) for prophylaxis. Concurrent medical conditions included fatty liver, hypertension and sleep disorder. Concomitant products included Hepatitis a vaccine inact (Havrix) and amitriptyline. On 09-MAY-2025, the patient received Havrix adult (left deltoid). On 09-MAY-2025, an unknown time after receiving Havrix adult, the patient experienced drug dose administration interval too short (Verbatim: The first dose had been given on February 7, 2025, and the second dose had been given on May 9, 2025, six months earlier). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 09-MAY-2025 The first dose had been given on 7th February 2025, and the second dose had been given on 9th May 2025, six months earlier, which led to Drug dose administration interval too short. No symptoms had been recorded. More
2841513 05/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation error Product preparation error
Shingrix is mixed with a plain diluent; Shingrix is mixed with a plain diluent; This non-serious cas... Shingrix is mixed with a plain diluent; Shingrix is mixed with a plain diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix is mixed with a plain diluent) and inappropriate dose of vaccine administered (Verbatim: Shingrix is mixed with a plain diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 08-May-2025 Physician asked that Shingrix was mixed with a plain diluent and not the one it comes with, what should they do. When the Medical Information Specialist tried to clarify if that was a hypothetical question or a real scenario, visitor ended the chat, so the Adverse Event report was being send as a preventive measure, only for awareness, since it might be a potential administration of Shingrix after reconstitution with an unapproved diluent. Reporter did not clarified what type of Healthcare Provider they were, and they declined consent to record their contact details into the system. Shingrix reconstituted with plain diluent instead of the supplied liquid conjugate, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. More
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